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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

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BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING Back to Search Results
Model Number 3851
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/19/2022
Event Type  malfunction  
Event Description
It was reported that tip detachment occurred.A 10mmx2.00mm wolverine cutting balloon was selected for use.During the procedure, it was noted that the distal tip of the device got separated outside the patient's body.The procedure was completed with a different device.No complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual and microscopic examination identified no issues with the balloon or blades.All blades were fully bonded onto the balloon.The balloon did not appear to have been subjected to any positive pressures.A visual and tactile examination found no kinks present along the hypotube.A visual and tactile examination found no damage along the shaft polymer extrusion.A visual and microscopic examination of the distal tip confirmed that the distal section of the tip had detached and was not returned for analysis.A visual and microscopic examination found no issue with the marker bands.
 
Event Description
It was reported that tip detachment occurred.A 10mmx2.00mm wolverine cutting balloon was selected for use.During the procedure, it was noted that the distal tip of the device got separated outside the patient's body.The procedure was completed with a different device.No complications were reported.
 
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Brand Name
WOLVERINE CORONARY CUTTING BALLOON MONORAIL
Type of Device
CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI  
Manufacturer Contact
jeff wallner
4100 hamline ave n
arden hills, MN 55112
6515811560
MDR Report Key16125292
MDR Text Key308371473
Report Number2124215-2022-56164
Device Sequence Number1
Product Code NWX
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number3851
Device Catalogue Number3851
Device Lot Number0029811168
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/19/2022
Initial Date FDA Received01/09/2023
Supplement Dates Manufacturer Received03/28/2023
Supplement Dates FDA Received04/11/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/22/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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